STIM: Stimulation to Improve Memory

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT03875326

Collaborator

National Institute on Aging (NIA) (NIH)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will test the effects of different doses of a form of non-invasive brain stimulation for the treatment of individuals with mild cognitive impairment (MCI) and dementia of the Alzheimer's Type (DAT).

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment Dementia of Alzheimer Type	Device: 1 mA HD-tDCS Device: 2 mA HD-tDCS Device: 3 mA HD-tDCS Device: Sham	N/A

Detailed Description

This research study is being done to learn important information about the effects of weak electrical stimulation on brain functioning in those with mild cognitive impairment (MCI) and dementia of the Alzheimer's type (DAT). The findings will help determine "how much" stimulation is needed to enhance memory and thinking abilities, how it affects brain functioning, and who is most likely to benefit. Ultimately, this information may guide treatment efforts for those at various stages of Alzheimer's disease. The study will use brain imaging to see whether these treatments change how participants learn and remember information. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) scans will be used. The study will also use cognitive tests and questionnaires to examine whether participants' memory (and related abilities) change because of treatment. The study will enroll participants with a diagnosis of MCI or DAT. It is expected but not required that participants will be co-enrolled in the University of Michigan Memory and Aging Project (UM-MAP; HUM00000382).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Eligible participants will be randomized 1:1:1:1 to receive either sham, 1mA, 2mA, or 3mA HD-tDCS for at least 5 sessions and up to 30 sessions using a blocked randomization design.Eligible participants will be randomized 1:1:1:1 to receive either sham, 1mA, 2mA, or 3mA HD-tDCS for at least 5 sessions and up to 30 sessions using a blocked randomization design.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Testing High Definition Transcranial Direct Current Stimulation (HD-tDCS) as Treatment of Mild Cognitive Impairment

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Sham Stimulation Sham (placebo) dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.	Device: Sham Participants will receive sham (placebo) HD-tDCS for 30 minutes, for between 5-30 sessions.
Experimental: 1 mA Dosage Stimulation 1 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.	Device: 1 mA HD-tDCS Participants will receive HD-tDCS at 1 mA for 30 minutes, for between 5-30 sessions.
Experimental: 2 mA Dosage Stimulation 2 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.	Device: 2 mA HD-tDCS Participants will receive HD-tDCS at 2 mA for 30 minutes, for between 5-30 sessions.
Experimental: 3 mA Dosage Stimulation 3 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.	Device: 3 mA HD-tDCS Participants will receive HD-tDCS at 3 mA for 30 minutes, for between 5-30 sessions.

Outcome Measures

Primary Outcome Measures

Change in Lateral Temporal Cortex Connectivity [Baseline fMRI and post-intervention (after tDCS sessions 5 & 30)]
Graph Theory Analysis via fMRI using arbitrary units of connectivity strength

Secondary Outcome Measures

Self-Report of Contentment with Memory [Baseline and post-intervention (after tDCS sessions 5 & 30)]
Multifactorial Memory Questionnaire (MMQ) Contentment Score
Self-Report of Memory Mistakes [Baseline and post-intervention (after tDCS sessions 5 & 30)]
Multifactorial Memory Questionnaire (MMQ) Ability Score
Self-Report of Memory Strategies Used [Baseline and post-intervention (after tDCS sessions 5 & 30)]
Multifactorial Memory Questionnaire (MMQ) Strategies Score
Change in Memory Functioning [Baseline and post-intervention (after tDCS sessions 5 & 30)]
Measured through change in the RBANS Delayed Memory Index
Change in Overall Fluid Cognitive Abilities [Baseline and post-intervention (after tDCS sessions 5 & 30)]
Measured through change in the NIH Toolbox Cognition Fluid Composite Score
Cumulative Working Memory Effects of HD-tDCS across daily sessions [Baseline Session through Session 6 then weekly up to final session]
Working memory accuracy measured by a discriminability ratio (2-back d' minus 0-back d') on a validated computerized N-Back task, measured after baseline (Session 1) and every intervention session (Sessions 2-6)
Cumulative Memory Accuracy Effects of HD-tDCS across daily sessions [Baseline Session through Session 6 then weekly up to final session]
Verbal memory accuracy measured by an accuracy score (percent correct) on a computerized Paired Associates task, measured after baseline (Session 1) and every intervention session (Sessions 2-6)
Cumulative Memory Reaction Time Effects of HD-tDCS across daily sessions [Baseline Session through Session 6 then weekly up to final session]
Verbal memory reaction time measured by a drift rate score (V; measured by the mean rate at which information is accumulated towards a boundary [correct or error response]) on a computerized Paired Associates task, measured after baseline (Session 1) and every intervention session (Sessions 2-6)
Tolerability of HD-tDCS [Prior to and immediately following each HD-tDCS session (<60 Minutes)]
Evaluated using standard questionnaires that arose from comprehensive reviews of the tDCS literature, this questionnaire was recently refined to include pre- and post-HD-tDCS symptom assessment. This will be administered prior to and immediately after every brain stimulation session (including sham).
Effectiveness of Blinding of HD-tDCS [Immediately following HD-tDCS sessions 5 and final session (<60 Minutes)]
Evaluated using a standard single question administered after every brain stimulation session (including sham).

Other Outcome Measures

Change in Default Mode Network Connectivity [Baseline fMRI and post-intervention (after tDCS sessions 5 & 30)]
Graph Theory Analysis via fMRI using arbitrary units of connectivity strength to measure changes in the Default Mode Network, along with strength in and between other networks
Change in Inhibition Ability [Baseline and post-intervention (after tDCS sessions 5 & 30)]
A priori intent to measure through change in the NIH Toolbox Flanker Inhibitory Control and Attention Test Score
Change in Conceptualization Ability [Baseline and post-intervention (after tDCS sessions 5 & 30)]
A priori intent to measure through change in the NIH Toolbox Dimensional Change Card Sort Test Score
Change in Picture Sequence Memory [Baseline and post-intervention (after tDCS sessions 5 & 30)]
A priori intent to measure through change in the NIH Toolbox Picture Sequence Memory Test Score
Change in Working Memory Ability [Baseline and post-intervention (after tDCS sessions 5 & 30)]
A priori intent to measure through change in the NIH Toolbox List Sorting Working Memory Test Score
Change in Processing Speed [Baseline and post-intervention (after tDCS sessions 5 & 30)]
A priori intent to measure through change in the NIH Toolbox Pattern Comparison Processing Speed Test Score
Cumulative Working Memory Performance Effects of HD-tDCS across daily sessions [Baseline Session through Session 6 then weekly up to final session]
A priori intent to explore d' change for each N-Back task condition (2-back, 0-back) in order to understand the overall effect of the HD-tDCS on task performance.
Change in Global Cognition [Baseline and post-intervention (after tDCS sessions 5 & 30)]
Measured through change in the Total RBANS Score
Change in Visuospatial Functioning [Baseline and post-intervention (after tDCS sessions 5 & 30)]
Measured through change in the RBANS Visuospatial Index score
Change in Language Functioning [Baseline and post-intervention (after tDCS sessions 5 & 30)]
Measured through change in the RBANS Language Index score
Change in Attention [Baseline and post-intervention (after tDCS sessions 5 & 30)]
Measured through change in the RBANS Attention Index score
Change in Memory Functioning [Baseline and post-intervention (after tDCS sessions 5 & 30)]
Measured through change in the RBANS Immediate Memory Index score
Change in Cognitive Functioning [Baseline and post-intervention (after tDCS sessions 5 & 30)]
A priori intent to measure through changes in RBANS subtest scores
Cumulative Cognitive Change across Daily Consecutive Sessions [After each HD-tDCS Session, daily]
Measured through change in Cogstate or other comparable computerized cognitive testing scores across consecutive daily sessions

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of Mild Cognitive Impairment (MCI) or dementia of the Alzheimer's type (DAT)
Must be MRI compatible, criteria that also apply for High Definition transcranial direct current stimulation (HD-tDCS; e.g., absence of metallic or electronic implants in the upper body or head)
Stable on relevant medications for at least 4 weeks prior to study enrollment